MedTrace Logo

Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

NCT01416194 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10497

Last updated 2024-04-22

Study results available
· View outcomes & findings →

Summary

This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

Bazedoxifene

Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

DRUG

Bisphosphonate

Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

DRUG

Raloxifene

Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-25
Primary Completion
2019-04-30
Completion
2019-04-30

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416194 on ClinicalTrials.gov